Structured Education Based on New Glucose Management Devices in Patients With Type 1 Diabetes Mellitus (Education)
Development and Efficacy of Individualized Professional Education Based on New Glucose Management Devices in Patients With Type 1 Diabetes Mellitus
Continuous glucose monitoring (CGM) and insulin pump, a new medical device, have been proved and highly recommended in the treatment of type 1 diabetes patients worldwide, and related technology development and market are growing rapidly.
In order to maximize the medical and socioeconomic effects of the latest blood glucose devices including CGM and insulin pump, structured education is necessary. In this study, we will develop patient-oriented structured education for patients with type 1 diabetes mellitus when applying CGM, and we will assess the efficacy of this education protocol for patients with type 1 diabetes using CGM.
研究概览
详细说明
In 50 patients with type 1 diabetes with over 7% of glycated hemoglobin, whose blood glucose level is not well controlled, and who are undergoing multiple daily insulin injection therapy or insulin pump therapy, continuous glucose monitoring (CGM) is applied to obtain basal continuous glucose levels for 1 week (window period of 2 week).
These 50 patients are 1:1 randomly assigned to 2 groups including control group and intervention group. Control group (n=25) applied CGM without structured education and after 3 months of applying CGM, continuous glucose data for 2 consecutive weeks and HbA1c level, and other glycometabolic parameters are collected. As a sequential extension clinical trial, those 25 patients in control group are provided structured education, followed by applying CGM for 3 months. Continuous glucose levels for 2 consecutive weeks and HbA1c level, and other glycometabolic parameters are collected.
In Intervention group (n=25), structured education program is provided for each patient from the time of enrollment, followed by applying CGM for 3 months. Continuous glucose levels for 2 consecutive weeks and HbA1c level and other blood tests are performed after the 3 months.
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习地点
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Seoul、大韩民国、135-710
- 招聘中
- Samsung Medical Center
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接触：
- Jae Hyeon Kim, M.D.,Ph. D
- 电话号码：82-2-3410-1580
- 邮箱：jaehyeonmd.kim@samsung.com
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Over 18 years old - under 70 years old patients with Type 1 diabetes
- Those who plan to use CGM G5
- Patients who consented to use CGM G5 in conjunction with Clarity
- Those who are using multiple insulin injections or insulin pumps for at least 3 months
- Those whose fasting c-peptide <0.6 ng / dL, or stimulated c-peptide <1.8 ng / dL
- Those with a glycated hemoglobin of 7.0% or more within the last 3 months
- Those who have never used a CGM for more than a month
- For women of childbearing age, those who agree to use appropriate contraception during the trial
- Those who voluntarily signed the agreement after the explanation of the clinical trial
Exclusion Criteria:
- Those with a history of severe hypoglycemia and acute ketoacidosis within the last 3 months
- Patients with chronic renal function greater than or equal to stage 4 (estimated glomerular filtration rate [assessed by MDRD (modification of diet in renal disease] <30 )
- Patients with acute myocardial infarction, unstable angina, coronary artery disease or stroke within the last 3 months
- Patients with adrenal insufficiency, pituitary dysfunction, medically uncontrolled hyperthyroidism or hypothyroidism
- Those taking medications that can affect the glucose metabolism (eg, corticosteroids, immunostimulants, etc.)
- Pregnant and lactating women
- A person who is deemed unsuitable for participation in clinical trials by examiners
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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安慰剂比较：Control
Without structured education when applying CGM for 3months, and as a sequential extension clinical trial, after 3 months, structured education is provided, followed by CGM apply
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Individualized professional education based on new glucose management devices in patients with type 1 diabetes mellitus
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有源比较器：Intervention
provide structured education when applying CGM for 3 months
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Individualized professional education based on new glucose management devices in patients with type 1 diabetes mellitus
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Percentage of time in target range 70-180 mg/dL
大体时间：3months (control and intervention groups) and 6months (for extension study in control group)
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Percentage of time in target range 70-180 mg/dL by continuous glucose monitoring system
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3months (control and intervention groups) and 6months (for extension study in control group)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Percentage of time in level 2 hypoglycemia (<54mg/dL)
大体时间：3months (control and intervention groups) and 6months (for extension study in control group)
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Percentage of time in level 2 hypoglycemia (<54mg/dL) by continuous glucose monitoring system
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3months (control and intervention groups) and 6months (for extension study in control group)
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Percentage of time in level 1 hypoglycemia (<70-54mg/dL)
大体时间：3months (control and intervention groups) and 6months (for extension study in control group)
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Percentage of time in level 1 hypoglycemia (<70-54mg/dL) by continuous glucose monitoring system
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3months (control and intervention groups) and 6months (for extension study in control group)
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Percentage of time in level 1 hyperglycemia (>180mg/dL)
大体时间：3months (control and intervention groups) and 6months (for extension study in control group)
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Percentage of time in level 1 hyperglycemia (>180mg/dL) by continuous glucose monitoring system
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3months (control and intervention groups) and 6months (for extension study in control group)
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Percentage of time in level 2 hyperglycemia (>250mg/dL)
大体时间：3months (control and intervention groups) and 6months (for extension study in control group)
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Percentage of time in level 2 hyperglycemia (>250mg/dL) by continuous glucose monitoring system
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3months (control and intervention groups) and 6months (for extension study in control group)
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Glycemic variability, reported as coefficient of variance (CV)
大体时间：3months (control and intervention groups) and 6months (for extension study in control group)
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Glycemic variability, reported as coefficient of variance (CV) by continuous glucose monitoring system
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3months (control and intervention groups) and 6months (for extension study in control group)
|
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Glycemic variability, reported as standard deviation (SD)
大体时间：3months (control and intervention groups) and 6months (for extension study in control group)
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Glycemic variability, reported as standard deviation (SD) by continuous glucose monitoring system
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3months (control and intervention groups) and 6months (for extension study in control group)
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Mean glucose by continuous glucose monitoring system
大体时间：3months (control and intervention groups) and 6months (for extension study in control group)
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Mean glucose by continuous glucose monitoring system
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3months (control and intervention groups) and 6months (for extension study in control group)
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HbA1C
大体时间：3months (control and intervention groups) and 6months (for extension study in control group)
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HbA1C
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3months (control and intervention groups) and 6months (for extension study in control group)
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glycated albumin
大体时间：3months (control and intervention groups) and 6months (for extension study in control group)
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glycated albumin
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3months (control and intervention groups) and 6months (for extension study in control group)
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Personalized education time for each patient
大体时间：baseline (intervention group) and 3months (for extension study in control group)
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Personalized education time for each patient
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baseline (intervention group) and 3months (for extension study in control group)
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Frequency of hypoglycemia
大体时间：3months (control and intervention groups) and 6months (for extension study in control group)
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Frequency of hypoglycemia
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3months (control and intervention groups) and 6months (for extension study in control group)
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Adverse event
大体时间：3months (control and intervention groups) and 6months (for extension study in control group)
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Adverse event occurred
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3months (control and intervention groups) and 6months (for extension study in control group)
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Percentage of time in target range 70-180 mg/dL
大体时间：6months (for extension study in control group)
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Percentage of time in target range 70-180 mg/dL by continuous glucose monitoring system
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6months (for extension study in control group)
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合作者和调查者
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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